Further concerns on Novartis' Elidel

22 January 2007

A US law case in Pennsylvania against Swiss rug major Novartis, involves a toddler who developed cancer due to a failure-to-warn about the risks associated with the topical drug Elidel (pimecrolimus). In an important decision sure to have an impact on many other cases in the USA, on October 16, 2006, a US District Court in Eastern Pennsylvania refused to grant the drugmaker's preemption motion in, Perry versus Novartis Pharma Corp, according to Online Legal Marketing Ltd, which offers a web site with up-to-date legal news, class action law suits, etc.

Elidel was approved by the US Food and Drug Administration on December 13, 2001, to treat atopic dermatitis, commonly known as eczema, in a cream applied directly to the skin, for patients over the age of two.

Elidel belongs to a class of immunosuppressant drugs known as calcineurin inhibitors. At the time of its approval, there were already concerns about an association between the drug and cancer because other calcineurin inhibitors that were used to treat organ transplant patients were known to increase the risk of cancer and lymphoma, and carried a Black Box warning to that affect. At the time of its approval, Elidel had also been found to increase the risk of cancer in animals when administered at high doses.

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